Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Plate, Fixation, Bone
510(k) Number K223342
Device Name MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System
Applicant
Crossroads Extremity Systems, LLC
6423 Shelby View Dr.
Suite 101
Memphis,  TN  38134
Applicant Contact Kim Strohkirch
Correspondent
Crossroads Extremity Systems, LLC
6423 Shelby View Dr.
Suite 101
Memphis,  TN  38134
Correspondent Contact Kim Strohkirch
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   JDR  
Date Received11/01/2022
Decision Date 03/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-